In the field of medicine one distinguishes between different diseases in the stomach-intestine-region of a living being, among others between achalasia and stenosis.
The case of achalasia in man concerns the inability of the stomach entrance to open up to admit food. For the treatment of this disease devices have been developed, in particular dilatators, to "burst" the stomach entrance. After such treatment the stomach entrance stays open constantly. Food subsequently taken in falls into the stomach by force of gravity. A pneumatic dilatator for introduction into the esophagus and for the treatment of achalasia in man is described in my U.S. Pat. No. 4,367,747. In this dilatator a balloon is used whose diameter is limited during inflation to a given upper limiting value. The dilatator comprises a balloon of a flexible material of little elasticity and a flexible tube of a given length which is passed therethrough. During the treatment, a gastroscope is passed through the tube. For inflating the balloon, an inflation device is provided. This device contains a capillary tube which at one end opens into the balloon. The other end is connected to a commercial blood pressure manometer having a drain or bleeding valve.
An organic or functional stenosis, relating to an inability to swallow liquid or compact food, concerns a condition which is caused by a disease of the esophagus. Here one distinguishes between peptic stenoses, stenoses after cauterization, stenoses after long stomach intubations, stenoses after irradiation, stenoses after operative anastomases, as well as others. Such a stenosis is, for example, located at the entrance of the stomach, but can also be located at the exit of the stomach. Due to the developement of new instruments and suitable techniques, most of these stenoses can be treated without operation. Many such treatments can be performed without hospitalization, although some require a short stay in the hospital. The most common form of treatment utilizes a bougie. In the course of such treatment, through admission of the bougie, an enlargement of the stomach-intestine-region is brought about. During one or more sessions, the stenosis is expanded by using a bougie, whose diameter is, for example, between 13 and 17 mm. The insertion of the bougie occurs either or without sight-control by means of an endoscope.
In the prior art, a bougie is known which consists primarily of a Teflon tube, which at one point has a "swell-out" or expanded portion of about 15 mm and which is slipped over an endoscope. It is a disadvantage of this bougie that one can only expand a constricted segment to a fixed value of 15 mm and that the physician during the introduction has to push the afore-mentioned "swell-out" of 15 mm through the throat of the patient. This is unpleasant to the patient and entails a certain risk of injury. With such a bougie, one can expand only narrow parts of the esophagus, but not other parts in the stomach-intestine-region of the patient.
Furthermore, it is known to use rubber and mercury bougies which have a flexible, conically tapering tip. A disadvantage of these bougies is their blind introduction into the esophagus and consequently a certain danger of perforation. Also with such bougies only constricted areas in the esophagus can be treated.
Furthermore a so-called metal or ring bougie is known which is pushed over a guide wire. The ring bougie is guided by the guide wire to the constriction which is to be enlarged. It is considered a disadvantage of such a bougie that only stenoses in the esophagus can be treated. Besides, the treatment is a complicated and long procedure, and this can be a heavy burden to the patient. A certain danger of perforation exists in this case as well.
A pneumatic bougie of the type having an inflatable balloon slipped over an endoscope and having an inflation device is disclosed in the German periodical "Deutsches Arzteblatt-Arztliche Mitteilungen", volume 44, pages 27 to 30, Nov. 5, 1982, in prticular on page 28, right column, paragraph 2.
With such a pneumatic bougie the danger of perforation is decreased considerably. With such a device, the endoscope along with the dilatator is introduced into the cavity. Under sight-control they are pushed forward until the stenosis which is to be treated surrounds the dilatator. The balloon is slowly inflated to a pressure of 300 mm Hg, whereby the constricted segment is enlarged. The diameter of the balloon is limited to 15 mm. Unfortunately, it has turned out that one cannot work delicately or sensitively enough with such a device. The balloon, which is formed as a cylinder, rests in the stenosis during the inflation procedure. During the treatment painful over-extensions can occur. Furthermore, with such an apparatus the treatment is limited to 15 mm, which corresponds to the diameter of the cylindricaL balloon.